ELIPSE is a research study looking two different types of surgery for men with high-risk localised prostate cancer.
Around 50,000 people are diagnosed with prostate cancer each year in the UK. Prostate cancer that has not spread elsewhere in the body, but is at risk of doing so, is called high-risk localised prostate cancer. Established treatment options for high-risk localised prostate cancer are surgery and radiotherapy. The surgery (an operation called a radical prostatectomy) involves removal of the entire prostate gland and, in some cases, the nearby lymph nodes.
Lymph nodes are part of the body’s immune system. Between 30-50% of men with high-risk disease get a recurrence of cancer, which means their cancer returns.
We are recruiting adult men in the UK with newly diagnosed localised high risk prostate cancer who are suitable for surgical treatment and are able and willing to give informed consent to participate.
Please see ‘Where can I take part?’ to check if your local hospital is participating.
If you would like to know more about ELIPSE, including information about taking part, please contact the ELIPSE study office at the University of Aberdeen on 01224 438161 or email elipse@abdn.ac.uk
If you are eligible, would like to take part and your local hospital is a study site, they will send you information about the ELIPSE study.
To take part, you will be asked to complete a consent form and a questionnaire about your health and quality of life.
After this you will be allocated at random to receive one of the treatments below:
• Surgery where the prostate and lymph glands are removed.
• Surgery where the prostate alone is removed.
There is an equal chance that you will be placed in either group.
The surgical team will arrange a date for your procedure. Whichever surgery you receive, you will continue to receive NHS care during your surgery and afterwards.
We will follow you up in the study for 3 years by sending you questionnaires to complete at home. We will collect some information from your medical notes about the surgery and any further treatment or complications you may have had. As part of your standard NHS care you will likely have regular PSA (prostate specific antigen) blood tests. We will also collect this information from your medical notes
You may not benefit personally from taking part in the study. However, by taking part, you will be directly helping us to understand the best treatment for men who need to have prostate cancer surgery in future.
We do not think that there are any possible disadvantages for men who take part in ELIPSE. Both types of surgery are already routinely being used in the NHS to treat patients with prostate cancer. There are always risks associated with all surgical procedures and steps are always taken to ensure that these risks are minimised. Whichever treatment group men are allocated to, their surgery will be performed by a competent and trained surgeon. Some of the main risks and benefits of each type of surgery are described below. But, taking part in the ELIPSE study, does not add additional risk over and above the risk of surgery itself. Ultimately, we do not know which of the two options is best and that is why we are doing this trial.
There might be a higher chance of cancer relapse if there is cancer within the lymph nodes not detected on scans before surgery.
There might be a lower chance of complications such as injury to nerves or blood vessels during the operation.
There might be a lower chance of complications such as fluid collection or clots in legs or lungs needing treatment
This might reduce the time taken to perform your operation.
There might be a lower chance of cancer relapse if there is cancer within the lymph nodes not detected on scans before surgery.
There might be a higher chance of complications such as injury to nerves or blood vessels during the operation.
There might be a higher chance of complications such as fluid collection or clots in legs or lungs needing treatment
This might increase the time taken to perform your operation, meaning a longer general anaesthetic.
Funding acknowledgement
This study is funded by the NIHR Health Technology Assessment (HTA) programme (NIHR152686). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The project is run by The Cardiff and Vale University Health Board.
The Cardiff and Vale University Health Board is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and, together with the University of Aberdeen, will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The Cardiff and Vale University Health Board and University of Aberdeen will keep identifiable information about you for at least 5 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information
https://cavuhb.nhs.wales/use-of-site/privacy-policy/ . You can also review the University of Aberdeen Privacy Notice at https://www.abdn.ac.uk/about/our-website/privacy